Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT - Full Text View

Purpose

The primary objective of this study is to assess the safety and efficacy of performing unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative therapy and tacrolimus plus methotrexate as the GVHD prophylaxis regimen. The goal is to demonstrate safety, aiming for a transplant related mortality rate (TRM) of < or equal to 40% at 100 days. A TRM of > or equal to 60% will be considered unacceptable. Another goal is to demonstrate efficacy by showing and overall survival of >40% at 1-year following transplant.

Condition	Intervention	Phase
Chronic Myeloid Leukemia Acute Myelogenous Leukemia Myelodysplasia Acute Lymphocytic Leukemia Severe Aplastic Anemia Non-Hodgkin's Lymphoma Lymphoproliferative Disease Multiple Myeloma Advanced Myeloproliferative Disease	Drug: Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF	Phase 2


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation

Resource links provided by NLM:

Genetics Home Reference related topics: core binding factor acute myeloid leukemia cytogenetically normal acute myeloid leukemia familial acute myeloid leukemia with mutated CEBPA

Drug Information available for: Busulfan Methotrexate Methotrexate sodium Fludarabine Fludarabine phosphate

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Acute Monoblastic Leukemia Acute Myeloblastic Leukemia Type 5 Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Acute Non Lymphoblastic Leukemia Aplastic Anemia Chronic Myeloid Leukemia Chronic Myeloproliferative Disorders Leukemia, Myeloid Lymphosarcoma Multiple Myeloma Myelodysplastic Syndromes

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:


Estimated Enrollment:	36
Study Start Date:	November 2002
Study Completion Date:	November 2007

Intervention Details:

Day Preparative Regimen for GVHD Prophylaxis

7 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
6 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
5 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
4 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
3 Fludarabine 30 mg/m(2)IV
2 REST Tacrolimus 0.01 mg/kg CIVI
1 REST 0 Unrelated Stem Cell/Bone Marrow Infusion
- 1 Methotrexate 5mg/m(2)IV
- 3 Methotrexate 5mg/m(2)IV
- 6 Methotrexate 5mg/m(2)IV
- 7 G-CSF 5mcg/kg SQ daily
- 11 Methotrexate 5mg/m(2)IV
- 90 Evaluate Response

Eligibility


Ages Eligible for Study:	15 Years to 61 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

No fully or single-antigen mismatched sibling donor is available to donate stem cells.
Age >15 and <61
ECOG PS < or equal to 2
Adequate renal function with serum creatinine <2.0 mg/dl
Pulmonary diffusing capacity >40% of predicted
Cardiac ejection fraction >40% as measured by radionuclide wall motion study or echocardiography
No active liver disease. Total bilirubin must be < or equal to 2.0 mg/dl. Alkaline phosphatase and AST must be less than three times the upper limit of normal. Patients with hepatitis C and active hepatitis B are eligible only if a liver biopsy is performed and there is < or equal to grade 2 inflammation. Patients wtih a history of HBV infection should be tested for HBeAg, antiHBe and HBV DNA (quantitative). Patients with active HBV viral replication should receive anti-viral therapy.
Negative serology for the human immunodeficiency virus (HIV)
Available HLA-matched donor (see HLA compatibility requirements below)
Signed informed consent from the recipient

Exclusion Criteria:

Ongoing active infection
Pregnancy and/or nursing
Active, uncontrolled CNS leukemia
Opinion of BMT Committee that autologous or mini-allogeneic transplant would be the preferable form of treatment
Receipt of any chemotherapy within 3 weeks of study entry except for hydroxyurea or imatinib mesylate. Use of interferon within 3 months of starting therapy.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516152

Locations


United States, California
University of California San Francisco
San Francisco, California, United States, 94143

Sponsors and Collaborators

University of California, San Francisco

Investigators


Principal Investigator:	Thomas G. Martin, M.D.	University of California, San Francisco

More Information

Additional Information:

UCSF Cancer Center Home Page This link exits the ClinicalTrials.gov site

No publications provided


Responsible Party:	Beth Davis, University of California San Francisco
ClinicalTrials.gov Identifier:	NCT00516152 History of Changes
Other Study ID Numbers:	UC-2214
Study First Received:	August 13, 2007
Last Updated:	January 22, 2009
Health Authority:	United States: UCSF Cancer Center Data Safety Monitoring Committee

Keywords provided by University of California, San Francisco:


Matched Unrelated Donor Stem Cell Transplantation Busulfan fludarabine Hematopoietic Disorder

Additional relevant MeSH terms:


Leukemia Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Myeloproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Bone Marrow Diseases Hematologic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma	Neoplasms Neoplasms by Histologic Type Busulfan Fludarabine Fludarabine phosphate Methotrexate Abortifacient Agents Abortifacient Agents, Nonsteroidal Alkylating Agents Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Dermatologic Agents

ClinicalTrials.gov processed this record on February 27, 2015